JPWO2007004353A1 - Instruction composition for medical device cleaning evaluation - Google Patents

Abstract

The present invention provides an indicator composition for cleaning evaluation comprising an extracellular matrix component and hemoglobin as a contamination model having a cleaning profile that approximates the actual contaminant attached to a medical device such as a surgical device.

Description

  The present invention relates to an indicator composition for cleaning evaluation of a medical instrument contaminated with body fluid or blood during surgery, etc., an indicator for cleaning evaluation using the indicator composition, and a method for cleaning evaluation of a medical instrument using the indicator And a medical device cleaning evaluation kit comprising a combination of a cleaning evaluation indicating tool and a color reaction reagent used in the evaluation method.

With the development of medical technology, the use of devices having complicated shapes and instruments made of special materials has become widespread, and a method for safely and reliably performing cleaning, disinfection and sterilization has been demanded.
In particular, the quality of the cleaning greatly affects the subsequent disinfection and sterilization processes, and therefore the evaluation method is important.

In recent years, establishment of cleaning evaluation methods in the medical field has been demanded, and international standards have been attracting attention for the evaluation criteria.
The indirect evaluation method, which is one of the cleaning evaluation methods, is an evaluation method that uses a contamination model that approximates the actual contamination, and how much contamination model remains after the cleaning process evaluated by the contamination model is performed. It is a method for evaluating the degree of cleaning of a contaminated medical device based on whether or not it is contaminated.

Conventionally used pollution models include a pollution model containing a mixture of egg yolk, pigment, mucin, and the like (for example, see Non-Patent Document 1).
As another contamination model, there is one in which hemoglobin and albumin, which are main components of blood, are attached to a stainless steel plate using fibrin (for example, see Patent Document 1).
International Publication No. WO97 / 27482 Pamphlet Infection Control 2004 Special Issue Point 209 for Cleaning, Disinfection, and Sterilization, Medica Publishing Co., Ltd., November 15, 2004, p.55

  However, the contamination model described in Non-Patent Document 1 hardly includes blood components and biological tissue components, which are main contaminants, and is clearly different from contamination due to blood components and tissue components. For this reason, in this contamination model, there is a problem that it is not possible to appropriately evaluate the cleaning process of surgical instruments contaminated with blood or tissue.

  In addition, the contamination model described in Patent Document 1 includes only blood components that are easily removed with an alkaline detergent or the like. However, in actual surgery, the main contaminants are blood and tissue components that are difficult to remove, so even in this contamination model, the actual contaminants that are difficult to remove. There is a problem that the cleaning process cannot be properly evaluated.

  The present invention has been made in view of the above-mentioned problems, and its purpose is to show behaviors that are closer to those of actual contaminants attached by surgery or the like than conventional contamination models, and to be easy to clean. It provides a contamination model that can adjust the degree arbitrarily.

As a result of intensive studies to solve the above-mentioned problems, the present inventor has found that the composition containing an extracellular matrix component and hemoglobin adheres to a medical device during surgery during the cleaning process. As a result, the present invention has been completed.
The indicator composition for cleaning evaluation of a medical device according to the present invention (hereinafter also referred to as “indicator composition”) is a composition containing an extracellular matrix component and hemoglobin.

According to the indicating composition of the present invention, it is possible to appropriately evaluate the degree of cleaning of a medical device to which contaminants derived from blood components and tissue components are attached.
Furthermore, in the indicating composition of the present invention, by adjusting the concentration of the extracellular matrix component in the composition or treating the composition with a disinfectant to denature the protein in the composition, Depending on the degree of contamination, the difficulty of cleaning the contamination model can be arbitrarily adjusted.

It is the top view (a) and cross-sectional schematic diagram (b) of the pointer for cleaning evaluation obtained in Example 1. It is a photograph which shows the residual condition of the composition on an indicator over time when the indicator which apply | coated the indicator composition from which the density | concentration of an extracellular matrix component differs is wash | cleaned. It is a graph which shows the time-dependent removal rate of a contamination model when the indicator which apply | coated the indicator composition from which the density | concentration of an extracellular matrix component differs is wash | cleaned.

Explanation of symbols

1 Test member 2 Indicating composition

The present invention will be described below based on an embodiment of the present invention, but the present invention is not limited to this.
The first object of the present invention is to provide an indicator composition comprising an extracellular matrix component and hemoglobin.

  The extracellular matrix component contained in the indicator composition of the present invention is composed of a network-like substance formed by extracellular substances existing continuously from the immediate vicinity to the outside of the animal cell membrane, and is mainly a fibrous protein , Composed of proteoglycan and cell adhesion protein.

  The above-mentioned fibrous protein constituting the extracellular matrix component includes collagen, elastin, etc., proteoglycan mainly includes core protein, glycosaminoglycan, etc., and cell adhesion protein includes fibronectin, laminin, Includes tenascin.

  Although the substance which comprises the extracellular matrix component of this invention is not specifically limited, It is preferable at the point that the difficulty of washing | cleaning can be adjusted with the density | concentration when it contains collagen and proteoglycan at least.

The extracellular matrix component can be obtained from various tissues of animals such as chickens, pigs, cows, horses, mice, and the like, but it is particularly preferable to obtain it from chicken cartilage because it can be obtained easily and inexpensively.
Specifically, a chicken cartilage finely cut is homogenized with a mixer, the homogenized one is strained with, for example, a stainless steel net or mesh cloth (for example, 12 mesh), and the strained liquid substance is appropriately diluted with water. The diluted aqueous suspension can be obtained as an aqueous suspension by further straining with a mesh cloth (for example, 100 mesh).

  The hemoglobin contained in the indicating composition of the present invention is a pigment protein composed of heme and globin present in erythrocytes, and is appropriately obtained from animals such as chickens, pigs, cows, horses, mice and the like by conventional methods. However, commercially available products may be used.

  When the extracellular matrix component is used as an aqueous suspension of about 0.1 to 50% by weight and hemoglobin is used as an aqueous suspension of about 1 to 10% by weight in preparing the indicator composition of the present invention, It is preferable from the viewpoint of improving the quality of a contaminated model product.

  The composition ratio of the extracellular matrix component and hemoglobin constituting the indicating composition of the present invention is not particularly limited, but is usually in the aqueous suspension with respect to 1 part by weight of the extracellular matrix component in the aqueous suspension. About 0.1 to 10 parts by weight of hemoglobin is appropriate.

The indicator composition of the present invention may contain serum proteins such as albumin and globulin in addition to the extracellular matrix component and hemoglobin described above, and albumin is particularly preferable as the serum protein.
When the indicating composition of the present invention contains a serum protein, the content is suitably about 1 to 10% by weight, for example, with respect to the entire indicating composition.

  Moreover, the indication composition of this invention may further contain myoglobin, and when it contains myoglobin, the content is about 1 to 10 weight% with respect to the whole indication composition, for example.

  Further, the indicator composition of the present invention may contain myosin, myosin filaments, actin and / or actin filaments, and when these substances are included, the content thereof is, for example, 1 to 10% by weight with respect to the indicator composition. % Is appropriate.

The indicator composition of the present invention may further contain lipids such as glycerides, waxes, sterol esters, phospholipids, glycolipids, etc., and when these lipids are included, the content thereof is, for example, 0 relative to the indicator composition. About 0.1 to 10% by weight is appropriate.
The indicating composition of the present invention may further contain fatty acids, higher alcohols, hydrocarbons and the like.

  In addition to the extracellular matrix component and hemoglobin, a substance selected from the group consisting of these serum proteins, myoglobin, myosin, myosin filament, actin, actin filament and lipid is included in the indicating composition of the present invention. This is preferable in that the contamination model is more approximate to actual contamination.

The indicator composition of the present invention can be produced by mixing an extracellular matrix component, hemoglobin and, if desired, an aqueous solution or aqueous suspension of the above optional components by a conventional method. In addition, naturally the composition containing only the component obtained from the same individual | organism | solid and the composition obtained directly from a natural product are not contained in the instruction | indication composition of this invention.
When the obtained indicating composition is stored for a long period of time, for example, it can be freeze-dried and stored, and resuspended in distilled water or physiological saline before use.

  The second problem of the present invention is to provide a medical instrument cleaning evaluation indicating tool obtained by adhering the above-described medical instrument cleaning evaluation indicating composition to a test member (solid support) and then solidifying it. .

  The material of the test member is preferably the same as the material of the medical device. Specifically, for example, metal such as stainless steel, aluminum, copper, brass, titanium, glass, and polyethylene, polypropylene, silicone resin, polychlorinated resin, for example. Resins such as vinyl, Teflon (registered trademark), polycarbonate, polyester, polymethacrylate, polystyrene, ABS, nylon, acetal resin, acrylic resin, fluororesin, methylenepentene resin, polyurethane, phenol resin, melamine resin, epoxy resin, etc. However, stainless steel, silicone resin and the like are particularly preferable.

In addition, the surface structure of the test member is preferably the same as or similar to the surface structure of a medical instrument or the like, and the shape is similar to a part that is difficult to be cleaned in the medical instrument, for example, a box lock portion of a forceps It is preferable that the shape is similar to a forceps in a gripping part or endoscope, but may be a plate shape, a disk shape, a rod shape, a tubular shape having a hollow structure, or the like.
Further, the surface of the test member may be changed in surface roughness in order to adjust the difficulty of cleaning, and may be polished with, for example, Japanese Industrial Standard polishing fine powder No. 150-180. The surface of the test member may be treated to adjust hydrophilicity and hydrophobicity.
The size of the test member is not particularly limited, but when the test member is a quadrangular plate, the vertical and horizontal lengths are about 0.5 cm × 5 cm to 3 cm × 10 cm, and the thickness is about 0.1 mm to 10 mm. If it is enough.

Although the method of attaching the indicator composition of the present invention to the test member is arbitrary, it is convenient to apply the liquid indicator composition directly to the test member. The coating amount is not particularly limited, but for example, about 1 to 50 mg per 1 cm ^{2 of the} test member is appropriate.

The applied indicator composition is then solidified. Solidification is easy by drying. In that case, the drying temperature and time are not particularly limited. For example, about 1 to 24 hours is sufficient at room temperature, and about 1 to 2 hours is sufficient at 40 ° C.
In addition, you may make 2 or more types of instruction | indication compositions for washing | cleaning evaluation differ in the difficulty of washing | cleaning on the same surface of one test member.
Further, when the test member has two or more surfaces, two kinds of indicating compositions having different cleaning difficulty levels are attached to two different surfaces (for example, the front surface and the back surface in the case of a plate shape). May be.

A substance in which the denatured protein is less likely to be removed than the protein before denaturation by denaturing the protein in the composition by immersing the indicator composition attached to the indicator of the present invention in a disinfectant or the like Behave as.
Therefore, if the medical device is treated with a disinfectant before cleaning, contaminants attached to the medical device are more difficult to remove, but the indicator composition of the present invention is treated with the disinfectant. For example, a contamination model approximated by such a contamination form can be obtained.

  Examples of the disinfectant used for the above purpose include sodium hypochlorite, poviniod, benzalkonium chloride, benzethonium chloride, chlorhexidine gluconate, alkyldiaminoethylglycine chloride, alkylpolyaminoethylglycine hydrochloride, glutaral, and phthalal. Peracetic acid, ethanol, isopropanol, formalin, cresol soap solution, acrinol, oxidol, hideten alcohol (trademark), iodotinchi (trademark), isodine (trademark), hideten (trademark), rivanol (trademark) and the like.

A third object of the present invention is to provide a cleaning evaluation method for contaminated medical devices.
In this method, for example, when actually cleaning a medical device, the above-described medical device cleaning evaluation indicator is cleaned with a contaminated medical device, and the indicator composition remaining on the indicator is detected, This can be done by determining the degree of cleaning of the medical device.

  Further, this method, for example, cleans the medical instrument cleaning evaluation indicator under a predetermined cleaning condition, for example, detects the residual degree of the indicator composition on the cleaning evaluation indicator after a predetermined time elapses. It is also possible to set the cleaning conditions for the medical device based on the above.

  In addition, this method sets, for example, the same conditions as the cleaning process for a contaminated medical instrument, and cleans the medical instrument cleaning evaluation indicator of the present invention under the cleaning condition, for example, every 10 minutes. When the indicator composition remaining in the device is detected and the cleaning time for each combination of the cleaning difficulty and the cleaning process is determined in advance, and based on this, the contaminated medical device and the cleaning process are combined This can also be done by determining the time required for cleaning.

  Further, in this method, for example, the medical instrument cleaning evaluation indicator of the present invention is cleaned under predetermined cleaning conditions prior to daily cleaning work. And that the contamination model has been removed to the same extent as usual, it is also used to confirm that the set cleaning process is operating normally.

  In the actual cleaning of the contaminated medical device, the evaluation indicator of the present invention was simultaneously cleaned, and it was set by detecting that the indicator composition remained on the indicator as much as usual. It is also used to confirm that the cleaning conditions are normal.

The cleaning agent and the cleaning process itself used for the above cleaning are the same as the cleaning agent and cleaning process of a normal medical device.
And according to the application purpose of the present invention, in addition to the contaminated medical device to be cleaned, the cleaning evaluation indicator of the present invention as described above is placed in the cleaning device, Only the cleaning evaluation indicator of the present invention is placed in the cleaning device and cleaned.

In addition, if the indicator to which the 2 or more types of cleaning evaluation composition which differs in the difficulty of washing | cleaning was put in the washing | cleaning device, the washing | cleaning degree of the contaminated medical instrument can be determined with a higher precision.
The detection of the presence or absence of the indicator composition remaining on the indicator, which is performed after the washing process or after the washing is completed, is performed when the residue of the indicator composition contains a coloring component that can be visually recognized, such as hemoglobin. You may determine the residual degree of this visually.
When determination with higher accuracy is required, it is preferable to use a color reaction of a substance constituting the indicator composition.

This method can be performed by a conventional method depending on the substance to be detected. When the substance to be detected is a protein, for example, Kjeldahl reaction, Raleigh reaction, Milon reaction, ninhydrin reaction, Pauli reaction, It is performed by xanthoprotein reaction, biuret reaction or the like. When the substance to be detected is a complex carbohydrate, for example, PAS reaction, muticarmine staining, alcian blue staining, colloidal iron staining, toluidine blue staining, and vest carmine staining are performed. When the substance to be detected is lipid, for example, it is performed by Sudan III staining, Oil Red 0 staining, Sudan Black B staining, Nile blue staining, or the like.
Since the indicator composition of the present invention contains a protein, the ninhydrin reaction widely used for the detection of the protein is particularly preferable.

  A fourth problem of the present invention is to provide a medical instrument cleaning evaluation kit comprising a combination of a cleaning evaluation indicator and a color reaction reagent used in the above-described cleaning evaluation method.

  This kit is predicted in advance according to the degree of difficulty in cleaning contaminants by surgery or the like, for example, with an indicator attached with two or more cleaning evaluation compositions having different levels of difficulty in cleaning, and the surgical site. A combination of a color reaction reagent corresponding to the contaminant is preferable, but a combination of the most standard cleaning evaluation indicator and a color reaction reagent such as a ninhydrin reaction reagent may also be used.

  The present invention will be described below with reference to examples and test examples, but the present invention is not limited to these examples and test examples.

Example 1
(1) Preparation of indicator composition Chicken cartilage (100 g) is cut into approximately 10 mm squares and homogenized with a mixer. The homogenated product is filtered through a stainless steel net (12 mesh), and water (40 ml) is added to the filtered liquid (40 g), followed by further filtering through a mesh cloth (100 mesh). A 50% aqueous suspension was prepared.

Hemoglobin (bovine-derived hemoglobin, manufactured by Tokyo Chemical Industry Co., Ltd.) (100 mg) and albumin (bovine-derived serum albumin, manufactured by Nacalai Tesque Co., Ltd.) (60 mg) were dissolved in distilled water (1.8 g) and obtained above. In addition to a 50% aqueous suspension of the extracellular matrix components (40 mg), an indicator composition (2 g) was prepared.
The indicator composition contains 1% by weight of extracellular matrix components including collagen and proteoglycan, 5% by weight of hemoglobin, and 3% by weight of albumin.
In the same manner as described above, indicator compositions were prepared in which only the concentration of the extracellular matrix component was changed to 5 wt%, 10 wt%, and 20 wt%.

(2) Preparation of indicator The indicator composition (70 μl) obtained above was applied to the surface of a stainless steel plate (50 mm × 15 mm × 0.1 mm) and dried at room temperature (25 ° C.) for 1 hour. This stainless steel plate was immersed in a 10% sodium hypochlorite solution, a 6% peracetic acid solution, an 80% ethanol solution and a 70% isopropanol solution for 3 minutes each and dried at room temperature for 1 hour for cleaning evaluation. I got an indicator. A plan view thereof is shown in FIG. 1a, and a schematic sectional view thereof is shown in FIG. 1b.

Test example 1
(1) Preparation of a contaminated medical device mimicry To reproduce a contaminated medical device, a slice of meat (50 g) containing porcine skin tissue, connective tissue and muscle tissue was placed on a stainless steel plate (50 mm × 15 mm × 0.1 mm) was applied to allow porcine tissue components to adhere. Next, bovine blood (70 μl) was added to the adhering surface and dried at 40 ° C. for 1 hour to prepare a mimic of a contaminated medical device.

(2) Cleaning The cleaning evaluation indicator obtained in Example 1 and the above-mentioned medical instrument mimetic in a cleaning solution obtained by dissolving Biotect 66 (manufactured by Kao Corporation) (60 ml) as a cleaning agent in water (5940 ml) Were immersed at 37 ° C. for 5 minutes, 15 minutes, 25 minutes, 35 minutes, and 45 minutes.

(3) Detection of residual contaminants Ninhydrin (200 mg) was added and dissolved in ethanol (1 ml), and distilled water (100 ml) was added thereto to obtain an analytical reagent for ninhydrin reaction. Using this reagent, each test piece obtained in the above washing process was stained. The result is shown in FIG.
Also, the weight of each dried test piece is measured, and the removal rate (% by weight) of the contamination model in each test piece from the weight of each test piece before the start of cleaning and the weight of each test piece after washing for a predetermined time. Was calculated. The result is shown in FIG.
As can be seen from FIG. 3, the degree of difficulty in washing differs depending on the concentration of the extracellular matrix component contained in the indicator composition, and it can be seen that the higher the concentration, the harder it is to wash.
Therefore, according to the indication composition of this invention, the difficulty of washing | cleaning of the composition which should be adhered on an indicator can be arbitrarily adjusted according to the degree of contamination of a medical device.

  This application relates to Japanese Patent Application No. 2005-192476 filed on June 30, 2005.

Claims (15)

  An indicator composition for evaluating cleaning of contaminated medical devices, comprising an extracellular matrix component and hemoglobin.   The indicating composition according to claim 1, wherein the extracellular matrix component is obtained from chicken cartilage.   The indicating composition according to claim 1 or 2, wherein the extracellular matrix component comprises at least collagen and proteoglycan.   The indicating composition according to any one of claims 1 to 3, further comprising one or more components selected from the group consisting of serum protein, myoglobin, myosin, myosin filament, actin, actin filament and lipid.   5. The indicator composition according to claim 4, wherein the serum protein is albumin.   The concentration of the extracellular matrix component in the aqueous suspension is 0.1 to 50% by weight, and the concentration of hemoglobin in the aqueous suspension is 1 to 10% by weight. The indicating composition according to item.   An indicator for cleaning evaluation of a contaminated medical instrument, wherein the indicator composition according to any one of claims 1 to 6 is adhered to and solidified on a test member.   8. The indicator composition of claim 7, which has been treated with a disinfectant.   The medical instrument cleaning evaluation indicator according to claim 7 or 8 is cleaned, the residual degree of the indicator composition on the indicator is detected, and the cleaning degree of the contaminated medical instrument is determined based on the result. A cleaning evaluation method for medical equipment, characterized in that:   The medical instrument cleaning evaluation indicator is washed with a contaminated medical instrument, and the degree of cleaning of the medical instrument is determined by detecting the degree of remaining indicator composition remaining on the cleaning evaluation indicator. The cleaning evaluation method for a medical instrument according to claim 9.   The medical instrument cleaning evaluation indicator is cleaned under predetermined cleaning conditions, and the residual degree of the indicating composition on the cleaning evaluation indicator after a predetermined time has been detected. Based on the result, the cleaning condition of the medical instrument is determined. The cleaning evaluation method for a medical instrument according to claim 9, wherein the cleaning evaluation method is set.   The medical instrument cleaning evaluation indicator is cleaned under a predetermined cleaning condition, and the residual degree of the indicating composition on the cleaning evaluation indicator is detected after a predetermined period of time. Based on the result, the cleaning process of the medical instrument is performed. The medical device cleaning evaluation method according to claim 9, wherein it is confirmed in advance that the device is operating normally.   The cleaning evaluation method according to claim 12, wherein the residual degree of the indicator composition is detected by a color reaction of the protein.   The cleaning evaluation method according to claim 13, wherein the protein color reaction is a ninhydrin reaction.   A medical instrument cleaning evaluation kit comprising a combination of a medical instrument cleaning evaluation indicator and a color reaction reagent used in the cleaning evaluation method according to any one of claims 9 to 14.